Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of 300 ir sublingual immunotherapy (slit) tablets in children suffering from grass pollen rhinoconjunctivitis

Conditions: Allergy

Summary: a phase iii study to evaluate the efficacy and safety of slit for grass pollen allergens compared with placebo for reduction of symptoms and rescue medication usage in children.


Eligibility criteria:
inclusion criteria: * male or female outpatients aged 5 to 17 years. * written consent / assent. * grass pollen-related allergic rhinoconjunctivitis for at least the last two pollen seasons. * sensitised to grass pollen (positive spt and grass pollen-specific ige values of at least class 2). * total symptom score on the retrospective rtss during the previous pollen season of greater than or equal to 12. exclusion criteria: * patients who have received any desensitisation treatment for grass pollen.

Keywords: sublingual immunotherapy grass pollen tablet allergic rhinoconjunctivitis
diabetes training program for health professionals from hermosillo, sonora

Conditions: Knowledge

Summary: primary health care is the medical assistance available to all individuals in a community and is considered the core of the health system. diabetes, among other chronic diseases, is a common reason for medical consultation in primary health care. worldwide and in mexico, the prevalence of diabetes has been increasing in recent decades, which also leads to an increase in the number of deaths. on the other hand, the annual cost of medical care for diabetes in the country has increased due to the exacerbation of complications and comorbidities associated, which are presented, among other causes, by a deficiency of knowledge in the diagnosis, evaluation, management and follow-up of type 2 diabetes, of health professionals (doctors, nurses, nutritionists) working in primary health care. the present study will allow evaluating the effect of a training program, is a single-cohort clinical study with pre- and post-intervention measurements lasting 6 weeks, including the initial and final measurements of health professionals currently working in primary health care of hermosillo sonora.

the study aims to improve knowledge in diabetes through the design and evaluation of a training program in health professionals (doctors, nurses and nutritionists) in primary health care. the hypothesis of the study is that the training program in diabetes aimed doctors, nurses and nutritionists in primary health care will significantly increase knowledge in diabetes.

Eligibility criteria:
inclusion criteria: * physicians, nurses and nutritionists of primary health care in hermosillo, sonora. * belonging to the health jurisdiction and the general hospital of the state * that provide consultation to patients with diabetes * age 20 years and less than 65 * desire of participate * sign up the consent form exclusion criteria: * do not meet the inclusion criteria

Keywords: knowledge in type 2 diabetes, training program primary health care
self-care training for family caregivers of persons with neurodegeneration

Conditions: Caregiver Burden; Caregiver Stress

Summary: the purpose of this study is to assess whether an 8-week mindfulness program enhances psychological well-being (e.g., stress, depressive symptoms), biological indicators of stress (e.g., inflammation), and cognitive function (e.g., attentional ability) in primary family caregivers of persons with dementia or a related neurodegenerative disease. a total of 232 primary family caregivers aged 50+ years of age will be recruited for this study and randomized to one of three groups: mindfulness meditation (mm), psychoeducation (psy) or caregiver respite (cr). all participants will complete three testing sessions: baseline (pre-intervention \[t1\]), post 8-week follow-up (post-intervention, \[t2\]), and 12-month follow-up (t3).

the purpose of this study is to assess the benefits of 2 virtual self-care programs - mindfulness meditation or a psychoeducation support group - for family caregivers of persons with a neurodegenerative disorder. both programs are 8-weeks in length. a third arm will include a respite-ony group, which may be considered "treatment as usual". outcomes of interest include psychological well-being (e.g., stress, depressive symptoms), biological indicators of stress (e.g., inflammation), and cognitive function (e.g., attentional ability). all participants will complete three testing sessions: baseline (pre-intervention \[t1\]), post 8-week follow-up (post-intervention, \[t2\]), and 12-month follow-up (t3). the target sample is 232 family/informal caregivers, aged 50+ years old. all sessions will be conducted using the zoom platform. participants will be required to go to lifelabs for blood collection. blood results will be shared with participants.

Eligibility criteria:
inclusion criteria: * 50+ years of age * currently a primary family caregiver * fluent in english exclusion criteria: * existing mindfulness practice * diagnosed/presenting with post-traumatic stress disorder; substance disorder; psychosis * unable to attend 8 sessions * no access to a computer or high-speed internet * not willing to be randomized
elevated serum hdl in four generations of a nashville family

Conditions: Hyperlipidemias

Summary: the purpose of this study is to determine the genetic basis of one family's hereditary hyper-hdl-emia using multiple modalities such as linkage analysis and gene array.

hdl, or good cholesterol, has been shown to protect against heart attack and stroke. how hdl works as a protective agent is not well understood. there is a family that has 4 generations of living members with high hdl level. in the study, after consent is obtained, we will obtain 2 tablespoons of blood from all the family members in order to study their cholesterol levels and to obtain dna in order to determine if there is a pattern of inheritance for this trait. we will also have them fill out a questionnaire about their medical history, diet and activity level as all of these can affect their hdl levels. in addition we will obtain additional blood (about 2 tablespoons) for plasma, white blood cells and also perform a biopsy to obtain skin cells from a matched pair of family members with and without the trait in order to determine which genes might be turned on and off because of this trait. we also wish to study other families who have members with high hdl cholesterol as well. these individuals will be identified from a core database.

Eligibility criteria:
inclusion criteria: * 26 living members of a family with hdl levels greater than 90mg/dl and several of whom will act as related age matched controls. * the investigators will also identify individuals in a lipid core database with hdl's of greater than 90mg/dl who have normal or low ldl and triglyceride levels and determine if they have normal or low ldl and triglyceride levels and determine if they have family members (parents or siblings) who also have high hdl cholesterol. exclusion criteria: * individuals who are not a member of the study family and individuals with high hdl's and elevated ldl and/or triglycerides.

Keywords: cholesterol hyperlipidemia gene array
targeted electrotherapy for aphasia stroke rehabilitation (teaser) - phase ii multi-center study

Conditions: Chronic Aphasia

Summary: this phase ii study aims to ascertain the effectiveness of hd-tdcs for adjunctive treatment of anomia in chronic aphasia post stroke. furthermore, it will help explore factors such as alternate outcome measures, subject selection criteria, and benefits of extended treatment duration. these results will be compared to an existing trial using conventional non-targeted tdcs with the same design and outcomes. patients will be treated with hd-tdcs while performing computerized anomia treatment. the basis behind this method is that language therapy is mediated by cortical areas that are most effectively activated during the training tasks, thus increasing electric stimulation in these areas may improve learning outcomes. to better understand the long term benefits of the adjunctive treatment, patients will be screened again four weeks and six months after study using the same anomia tests. if hd-tdcs shows promising results in increasing the learning outcomes of anomia treatment, a phase iii trial can be considered.


Eligibility criteria:
inclusion criteria: * one-time ischemic stroke in the left hemisphere * greater than 6-months post-stroke onset * between 25 and 75 years of age * aphasia diagnosis (as determined by pre-treatment language-based testing) * right-handed (before the stroke) * native speaker of english * ability to provide informed written or verbal consent exclusion criteria: * clinically reported history of dementia, alcohol abuse, psychiatric disorder, traumatic brain injury, or extensive visual acuity or visual-spatial problems * factors contraindicative of tdcs administration (sensitive scalp, previous brain surgery) * prior history of epileptic or unprovoked seizures occurring during the previous 12 months. * presence of metal implants of claustrophobia (not able to undergo mri) * pregnancy * presence of any other neurological disease than stroke * childhood history of speech, language, hearing, or intellectual impairment

Keywords: stroke anomia
health2016: monitoring chronic disease and risk factors in the general population

Conditions: Micronutrient Deficiency; Cardiovascular Disease; Allergy; Respiratory Disease

Summary: health2016 is a general population cross-sectional study aimed at completing af monitoring program for monitoring chronic disease and risk factors in the period 2006 to 2016. similar studies have been performed in 2006, 2010, and 2013.

a random sample of 18-69 year-olds living in 10 municipalities in the capital region of denmark is invited to a health examination including measurements of anthropometry, lifestyles, symptoms and diagnoses of diseases, blood pressure, resting heart rate, muscle strength, fitness, lung function, allergy tests, and biochemistry (lipids, liver and kidney function, vitamin d status, salt excretion, iodine status). trends in these parameters over time will be assessed.

Eligibility criteria:
inclusion criteria: general population sample randomly selected from persons living in 10 municipalities in the capital region of denmark. age 18-69 years. danish citizenship, born in denmark exclusion criteria: * pregnancy

Keywords: micronutrients blood pressure allergy lung function
transcutaneous measurement of carbon dioxide versus current sedation practices in sedated patients

Conditions: Colonoscopy

Summary: does transcutaneous carbon dioxide partial pressure (tcco2) monitoring detect hypoventilation prior to current sedation monitoring practices in order to prevent hypoxemia in sedated patients undergoing colonoscopies?


Eligibility criteria:
inclusion criteria: * patients requiring sedation for colonoscopy exclusion criteria: * patient refusal

Keywords: carbon dioxide tcc02 hypoventilation endoscopic elective colonoscopy and requiring sedation
incidence and reasons for preoperative anemia in elective lower joint arthroplasty

Conditions: Anemia; Arthroplasty, Replacement, Hip; Arthroplasty, Replacement, Knee

Summary: preoperative anemia is an independent risk factor for the need for allogeneic transfusion during surgery and increased postoperative morbidity. treatment of preoperative anemia is recommended. however the type of preoperative anemias in elective hip- and knee surgery has only been sparsely studied. this observational study aims to investigate the incidence and type of anemias prior to elective hip- and knee arthroplasty.

preoperative anemia is an independent risk factor for the need for allogeneic transfusion during surgery and increased postoperative morbidity. in elective orthopedic surgery, international guidelines recommends treatment of preoperative anemia including the use of iron supplements for anemias associated with iron deficiency. in addition, low iron stores in both anemic and non-anemic patients may delay postoperative hemoglobin recovery. however, the reasons for preoperative anemia and the prevalence of patients with low iron stores have only been sparsely studied in elective hip- and knee arthroplasty. this observational study aims to investigate the incidence and type of anemias prior to elective hip- and knee arthroplasty.

Eligibility criteria:
inclusion criteria: * age \> 18 years * scheduled for elective primary hip- or knee replacement. exclusion criteria: * not possible to obtain preoperative blood sample.

Keywords: patient blood management preoperative anemia hip replacement knee replacement
survey of qrs frequency at various left ventricular pacing sites for cardiac resynchronization

Conditions: Cardiomyopathies; Congestive Heart Failure

Summary: lv pacing at various sites with recording of ecg and subsequent signal analysis at different sites.

during routine cardiac resynchronization pacemaker or implantable defibrillator (icd) implantation (including de-novo and upgrade from standard device, additional pacing within 3 different coronary veins will be performed in combination with a previously implanted right ventricular pacing or icd lead. the resulting electrocardiogram signal will be analyzed afterwards. a time-frequency analysis (tfa) of several ecg leads at each paced site will be performed and compared. the results of the tfa analysis will not be used to select pacing lead location in this study. the patient will then receive the left ventricular pacing lead in the standard manner.

Eligibility criteria:
inclusion criteria: * standard implantation for cardiac resynchronization icd or pm implantation * cardiomyopathy with lvef \<35% * qrs duration greater than 120 msec exclusion criteria: - age less than 18 years
fast-acting subperception study (fast)

Conditions: Chronic Pain

Summary: study to demonstrate the value of fast-acting subperception (fast) using the spectra wavewriter™ spinal cord stimulator system in the treatment of chronic pain


Eligibility criteria:
key inclusion criteria: * chronic pain of the trunk and/or limbs for at least 6 months with back pain greater or equal to leg pain. * 22 years of age or older at time of enrollment * able to independently read and complete all questionnaires and assessments provided in english * signed a valid, irb-approved informed consent form (icf) provided in english key exclusion criteria: * any pain-related diagnosis or medical/psychological condition that, in the clinician's best judgment, might confound reporting of study outcomes * significant cognitive impairment that, in the opinion of the investigator, would reasonably be expected to impair the study candidate's ability to participate in the study * breast-feeding or planning to get pregnant during the course of the study or not using adequate contraception * participating, or intends to participate, in another clinical trial that may influence the data that will be collected for this study
observational study to determine the effectiveness and safety of vismodegib (erivedge®) in participants with locally advanced basal cell carcinoma (labcc)

Conditions: Carcinoma, Basal Cell

Summary: the primary purpose for this multi-center, non-interventional study is to evaluate the duration of response defined as duration from first documented response of complete response (cr) or partial response (pr) until disease progression (as determined by the treating physician) for participants with labcc.


Eligibility criteria:
inclusion criteria: * histologically confirmed iabcc (inappropriate for surgery or radiotherapy) * participant is not included in any other trial * male or female participants are included in the pregnancy prevention program exclusion criteria: participants for whom treatment with vismodegib is contraindicated according to the smpc, which has been in effect at the time of treatment with vismodegib, including: * hypersensitivity to the active substance or to any of the excipients * women who are pregnant or breastfeeding * women of childbearing potential who do not comply with the vismodegib pregnancy prevention programme * coadministration of st john's wort (hypericum perforatum)
anxiety level assessment of anesthesia providers during covid-19 pandemic

Conditions: Anxiety

Summary: healthcare providers caring for acutely ill or critical patients are exposed to constant stressful situations that can lead to psychiatric manifestations. depression and anxiety derived from stressful work environments can negatively impact the ability to perform at full capacity directly affecting the quality of care the patients receive. the severe acute respiratory syndrome coronavirus 2 infection created a sudden and deep crisis involving every sector worldwide not only affecting sick patients and the healthcare system but also the economy, politics, food, and drugs and social interactions. hospital workers have experienced the crisis first-hand and have witnessed constant death, a decrease in personal protective equipment supplies, exposure to contracting the virus, risk of contagion to others, and overburdened hospital capacity. the aim of this study is to evaluate how the coronavirus disease 2019 (covid-19) pandemic has affected healthcare workers. specifically, to evaluate levels of anxiety and identify factors contributing to anxiety on faculty, residents, and nurse anesthetists in our institution.

the coronavirus disease 2019 (covid-19) pandemic has affected multiple aspects of everyday life worldwide. pandemics unleash a societal sense of fear and anxiety. hence, the covid-19 pandemic have had a profound impact on mental health. this has led to substantial research on this topic; however, literature evaluating the mental health effects of the pandemic on small groups of people is scarce. healthcare workers have undergone significant psychological pressure and stress during viral surges of this pandemic. furthermore, the levels of anxiety vary as the number of cases varies between regions and across time. after approval by the institutional review board (protocol # 160167), a cross-sectional study was conducted to identify anxiety levels during the covid-19 pandemic among anesthesia providers at our institution. the participants included faculty anesthesiologists, anesthesiology residents, certified registered nurse anesthetists, and nurse anesthetists students. data were collected from august 26 to september 15, 2020. a questionnaire containing the general anxiety disorder-7 (gad-7) scale, followed by a set of questions with binary answers to evaluate the presence or absence of anxiety-related factors during the covid-19 pandemic, was administered through direct approach and voluntary participation of the subjects.

Eligibility criteria:
inclusion criteria: * anesthesiology providers at augusta university medical center (au) (active resident enrolled in the anesthesiology residency program of augusta university, anesthesiologist and certified registered nurse anesthetist) * willingness to participate in the study exclusion criteria: * refuses to participate

Keywords: anxiety mental health covid-19 coronavirus
risk of coccidioidomycosis in patients receiving anti-tnf and other biologic agents for an inflammatory arthritis

Conditions: Coccidioidomycosis; Rheumatoid Arthritis

Summary: the goal of the project is to study the risk of coccidioidomycosis (valley fever) in patients receiving anti-tnf and other biologic agents for inflammatory arthritis in tucson, arizona.

retrospective chart review of all patients with an inflammatory arthritis seen at the university rheumatology clinic since january 2000.

Eligibility criteria:
inclusion criteria: * all active patients with an inflammatory arthritis seen at the university of arizona from january 2000 exclusion criteria: * none

Keywords: tnf inhibitors biologic agents coccidioidomycosis rheumatoid arthritis
a trial of single- and multiple-doses of aripiprazole in adult subjects with schizophrenia or bipolar i disorder

Conditions: Schizophrenia; Bipolar I Disorder

Summary: the primary objective of this trial is to evaluate the pharmacokinetics (pk) of aripiprazole long-acting injectable (lai) (420 mg) following deltoid or gluteal muscle administration in adult subjects with schizophrenia or bipolar i disorder.


Eligibility criteria:
inclusion criteria: * male and female subjects between 18 and 64 years of age, inclusive. * body mass index of 18 to 35 kg/m2, inclusive. * a current diagnosis of schizophrenia or a current diagnosis of bipolar i disorder as defined by dsm-5 criteria. * prior history of tolerating aripiprazole per investigator's judgment. exclusion criteria: * subjects who have met dsm-5 criteria for substance dependence within the past 180 days * use of any psychotropic medications other than their current non-aripiprazole antipsychotic or mood stabilizer(s) medication or subjects who use more than one antipsychotic or mood stabilizer(s) medication at screening. * subjects may not receive varenicline beyond screening. * use of any prescription medication not specifically approved by the medical monitor. * females who are pregnant or lactating. a negative serum pregnancy test must be confirmed prior to the first dose of imp for all female subjects. * subjects who had participated in any clinical trial involving a psychotropic medication within 1 month prior to enrollment; subjects who had participated in a previous aripiprazole lai trial within the last 1 year (ie, enrolled but did not receive aripiprazole lai); or who had previously enrolled and received imp in an aripiprazole lai clinical trial. * any major surgery within 30 days prior to enrollment or scheduled/elective surgery during the trial. * subjects currently in an acute relapse of schizophrenia. * subjects with a current dsm-5 diagnosis other than schizophrenia or bipolar i disorder * electroconvulsive therapy must not be conducted within 2 months prior to administration of the imp * subjects with a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia as assessed by the investigator. * history of or current hepatitis or acquired immunodeficiency syndrome or carriers of hbsag, anti-hcv, and/or hiv antibodies. * history of any significant drug allergy or known or suspected hypersensitivity, in particular to aripiprazole or other quinolinones. * subjects deemed intolerant of receiving injections.